The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) identifies female sexual arousal disorders and female orgasmic disorders as specific diagnoses.
Statistical estimates vary greatly, but it is thought that the overall prevalence of female orgasmic disorders may be up to 76% of all women (Berraan et al. Curr Opin Urol. November 1999; 9(6):563-8).
There are several medical conditions—diabetes, thyroid disorders, etc. that can affect orgasmic ability (Bultrini et al., J Sex Med. November 2004; 1(3):337-40; Dorurk et al., Arch Androl. January-February 2005; 51(1):1-6). Additionally, many medications themselves also have this potential, such as blood pressure medicines and anti-depressants (Okeahialam et al., J Natl Med Assoc. April 2006; 98(4):638-40; Harv Mens Health Watch. February 1999; 3(7):7-8; Story, J Sex Res. May 1974; 10(2):132-49).
Researchers have been cognizant of the observations that the above identified conditions and medicaments result in decreased or hindered blood flow to the clitoral region of females, thus causing or, at a minimum, exacerbating such problems (Berman et al., Curr Opin Urol. November 1999; 9(6):563-8; Park et al., J Urol. September 2002; 168(3):1269-72).
The female sexual response cycle is divided into four phases: (1) excitement; (2) plateau; (3) orgasm; and (4) resolution. The device of the present invention is intended to focus specifically on the most difficult transition, namely from plateau to orgasm.
The clitoris is the most sensitive sexual body part. It is the only organ in the human body to have no other function than pleasure. The clitoris is comprised of the glans (head), the shaft (continuing towards the pubic bone), and divides into two “legs” (crura) that surround the vaginal opening with erectile tissue (the vestibular bulbs). Typically, the general reference to the clitoris usually means the glans.
During orgasm, the clitoris becomes erect from blood—engorgement—and pulls under the hood of the clitoris.
Mechanical treatment approaches have included vibrators, and one device uses a suction pump placed on the clitoris to create engorgement with manually controlled pulsation (Billups et al., J Sex Marital Ther. October-December 1001; 27(5):435-41; U.S. Pat. No. 6,464,653). This device applies vacuum pressure to the clitoris in an effort to promote engorgement of the clitoris with blood.
There are several U.S. Patents related to similar devices in an effort to treat the various conditions related herein. U.S. Pat. No. 6,464,653 ('653) describes a device and method for treating female sexual dysfunction that promote blood flow to the genital region, specifically the clitoris of a female patient. The background section discusses the problem of female erectile dysfunction and clitoral blood flow. The '653 patent references Park et al., a study that shows collagen can build up in the clitoral blood vessels when arterial inflow to the clitoris is compromised.
Clitoral erectile insufficiency or reduced clitoral arterial flow may be caused by atherosclerosis, diabetes, or age-related causes, among other factors. Reduced clitoral arterial flow may lead to fibrosis of the clitoral cavernosa and reduced clitoral physiological function. In an animal model, researchers demonstrated that significant collagen synthesis occurs when the arterial inflow to the clitoris is compromised. This work demonstrated the importance of maintaining arterial flow to the clitoris to prevent collagen synthesis and fibrosis on the smooth muscle (Park; et al., Int J Impot Res. 9:27-37, 1997).
It is believed that the difficulty or inability to achieve clitoral tumescence may be related to and associated with other symptoms of female sexual arousal disorder. Clitoral stimulation and tumescence are important aspects of female sexual arousal. Tumescence or engorgement occurs when the clitoris fills with blood and, during sexual arousal, the smooth muscles within the clitoris relax and the arterial walls dilate. This results in an increase in blood flow leading to tumescence and extension of the glans clitoris.
According to the International Consensus Report on Female Sexual Dysfunction, Female Sexual Arousal Disorder (FSAD) is defined as the persistent or recurrent inability to attain or maintain adequate genital lubrication or swelling responses resulting in personal distress. FSAD may be expressed as a lack of subjective excitement or lack, of genital (lubrication/swelling) or other somatic responses (AFUD Consensus Report of FSD, 1998).
The device of the '653 patent is designed to increase blood flow in the clitoris to assist a woman to achieve clitoral engorgement, and are applicable to the treatment and diagnosis of female sexual disorders. Such designs are meant to increase blood flow by creating a vacuum around the clitoris.
However, one of the major limitations of the '653 device is the immediate area to which the suction pressure is applied. The suction pressure is only applied directly to the clitoris. The surrounding tissues will fail to be accessed for recruitment of additional capillaries in order to increase arterial flow to the clitoris. Furthermore, even if the '653 device were extended to regions outside of the clitoris proper, the suction pressure alone is unlikely to resolve the negative effects of collagen buildup in the surrounding areas of the clitoral tissues. Collagen synthesis and resulting buildup are best dealt with through a means of physical assault upon the relevant area, namely through external physical pressure against and/or stimulation to the relevant area.
The device of the '653 patent also includes a battery-operated vacuum pump and a disposable vacuum cup, wherein the vacuum cup is placed over the clitoris and the pump is activated to create a vacuum which draws blood into the clitoris, causing tumescence. The vacuum cup is attached to the vacuum pump and is activated by a button or switch on the vacuum pump or a housing thereof. A control valve, e.g. on an opposite side of the vacuum pump or housing, controls the amount of vacuum applied. By manually covering and uncovering the aperture with e.g. a finger of the patient or of the patient's partner, suction pressure in the suction applicator can be varied, rapidly if desired, to promote stimulation of the clitoral region. Additionally, modulation of suction pressure serves to refresh arterial blood flow in the clitoris. By cycling arterial blood through the clitoris, the blood is better able to pick up collagen and accelerate its removal. Removal of collagen build-up and Fibrosis on the smooth musical thus is facilitated and encouraged. However, as discussed supra, vacuum pressure alone is unlikely to be the most effective means of accomplishing such a task.
The '653 device must therefore rely on a manually operated vacuum pump in order to cycle through on-and-off stages of the device. This is far from an optimal design in that it is incumbent upon the device user to control the cycling of the vacuum in order to deliver the suction pressure to the clitoris. This is yet another limitation of the prior art device which is remedied by the device of the present invention. Moreover, having vacuum pressure alone is insufficient to increase the arterial flow to the clitoral region for proper clitoral tumescence, irrespective of the size of the vacuum cup through which such pressure is delivered. What is needed is a means of combining such vacuum pressure with additional features, thereby enabling the device to recruit blood flow from additional regions in an effort to achieve tumescence or engorgement.
The device of the '653 patent offers a long-term treatment solution, with results not expected for several weeks of regular use. This provides for a diminished likelihood of device use for those individuals in need of immediate treatment.
There is a current need in the field for the present invention, as there has been no previous device available which combines mechanical vibration, suction and oscillation, in one machine.